Back to resultsDo Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, adult, safety, reactogenicity
Eligibility Criteria
Inclusion Criteria:
- Employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare
- By self report, have had 2 or more doses of trivalent inactivated influenza vaccine (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia;
- Consent to the study, including two injections one month apart, with one being placebo and one a dose of TIIV;
Exclusion Criteria:
- Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or Guillain Barre syndrome with onset within 6 weeks of vaccination);
- Has previously received a dose of TIIV for the current influenza season.
- Receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is >7 days);
- Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vaccine, then placebo
Placebo, then vaccine
Arm Description
1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment followed by 1 injection of normal saline placebo, 0.5mL/dose, 28 days later
1 injection of normal saline placebo, 0.5mL/dose followed by 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment, 28 days later
Outcomes
Primary Outcome Measures
Systemic adverse event
Any systemic adverse event, self-reported
Secondary Outcome Measures
Full Information
NCT ID
NCT02263027
First Posted
October 8, 2014
Last Updated
January 13, 2016
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02263027
Brief Title
Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?
Official Title
Do Some Healthy Adults Consistently Have Systemic Reactions to Trivalent Inactivated Split Virus Influenza Vaccines?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated with systemic reactions in these workers.
Detailed Description
Randomized controlled trials of split virus vaccines in healthy adults have not been able to detect an increase in systemic adverse events compared to control vaccination. These trials do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo and vaccine. There is a small population of healthcare workers who report consistent systemic symptoms after split virus vaccination which may occur because a small group of healthy adults have true physical reactions to components of the vaccine or excipients. If this is true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray vaccines - might be expected to be better tolerated by these people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza vaccine, adult, safety, reactogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine, then placebo
Arm Type
Experimental
Arm Description
1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment followed by 1 injection of normal saline placebo, 0.5mL/dose, 28 days later
Arm Title
Placebo, then vaccine
Arm Type
Experimental
Arm Description
1 injection of normal saline placebo, 0.5mL/dose followed by 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment, 28 days later
Intervention Type
Biological
Intervention Name(s)
Vaccine
Other Intervention Name(s)
Trivalent inactivated influenza vaccine
Intervention Description
Licensed trivalent inactivated influenza vaccine
Primary Outcome Measure Information:
Title
Systemic adverse event
Description
Any systemic adverse event, self-reported
Time Frame
7 days after each injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare
By self report, have had 2 or more doses of trivalent inactivated influenza vaccine (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia;
Consent to the study, including two injections one month apart, with one being placebo and one a dose of TIIV;
Exclusion Criteria:
Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or Guillain Barre syndrome with onset within 6 weeks of vaccination);
Has previously received a dose of TIIV for the current influenza season.
Receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is >7 days);
Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison J McGeer, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?
We'll reach out to this number within 24 hrs